Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage
immunology company dedicated to enabling normal lives for people
with autoimmune diseases, today reported corporate updates and
financial results for its fiscal fourth quarter and fiscal year
ended March 31, 2023.
“During the past quarter, we made significant progress with
IMVT-1402, including receiving the IND clearance by the FDA, and
the initiation of a Phase 1 clinical trial following the approval
by MEDSAFE to proceed,” said Pete Salzmann, M.D., chief executive
officer at Immunovant. “This is an important step as we seek to
expeditiously generate Phase 1 data and accelerate a global
development program for IMVT-1402.”
Clinical Development
Updates:IMVT-1402:Immunovant received IND
clearance for IMVT-1402 from the U.S. Food and Drug Administration
(FDA) and initiated a Phase 1 clinical trial of IMVT-1402 in
healthy volunteers in New Zealand after approval of the CTA by the
regulatory authority, MEDSAFE. The clinical trial will evaluate the
safety, tolerability and pharmacodynamic profiles of IMVT-1402, a
subcutaneously administered, FcRn inhibitor. In the
multiple-ascending dose (MAD) portion of the study, Immunovant
plans to evaluate subcutaneous doses of 300 mg and 600 mg, at a
concentration of 150 mg/mL vs. placebo.
Initial data from single-ascending dose cohorts are expected in
August/September 2023 and initial data from MAD cohorts are
expected in October/November 2023. In a head-to-head,
placebo-controlled nonclinical study, IMVT-1402 has been observed
to achieve similarly deep IgG reduction as batoclimab and have
minimal or no impact on levels of albumin and low-density
lipoprotein cholesterol at doses well above the anticipated human
effective dose. Immunovant believes this profile could be best in
class.
Batoclimab:A Phase 2 proof-of-concept clinical
trial of batoclimab in GD was initiated in Germany, with initial
results expected in the fourth quarter of calendar year 2023.
As previously disclosed, Immunovant expects to have initial
results from period 1 of the Phase 2b clinical trial in CIDP in the
first half of calendar year 2024 and expects to have top-line
results from the Phase 3 MG clinical trial and the Phase 3 TED
program in the second half of calendar year 2024 and the first half
of calendar year 2025, respectively.
Financial Highlights for Fiscal Fourth Quarter Ended
March 31, 2023:Cash Position: As of March
31, 2023, Immunovant’s cash and cash equivalents totaled $376.5
million, which is expected to fund operations into the second half
of calendar year 2025.
R&D Expenses: Research and development
expenses were $51.8 million for the three months ended March 31,
2023, compared to $32.0 million for the three months ended March
31, 2022. The increase was primarily due to higher batoclimab
program-specific research and development costs (including contract
manufacturing costs), cross-indication clinical studies and
clinical research costs and personnel-related costs. These
increases were partially offset by lower contract manufacturing
costs related to the development of IMVT-1402, which were initiated
in the prior-year period.
G&A Expenses: General and administrative
expenses were $12.4 million for the three months ended March 31,
2023, compared to $15.2 million for the three months ended March
31, 2022. The decrease was primarily due to lower personnel-related
expenses and financial advisory, legal, and other professional
fees.
Net Loss: Net loss was $59.4
million ($0.46 per common share) for the three months
ended March 31, 2023, compared to $47.2
million ($0.41 per common share) for the three months
ended March 31, 2022. Net loss for the three months ended
March 31, 2023 and 2022 included $7.5 million and $11.9 million,
respectively, related to non-cash stock-based compensation
expense.
Common Stock: As of March 31, 2023, there were
130,329,863 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Year Ended March 31,
2023:R&D Expenses: Research and
development expenses were $160.3 million for the fiscal year ended
March 31, 2023, compared to $101.8 million for the fiscal year
ended March 31, 2022. The increase was primarily due to higher
batoclimab program-specific research and development costs
(including contract manufacturing costs), increased
personnel-related expenses and higher costs related to
cross-indication clinical studies and clinical research.
IPR&D Expenses: Acquired in-process
research and development expenses were $10.0 million for the fiscal
year ended March 31, 2023, related to the achievement of a
development and regulatory milestone for batoclimab in MG as
required under the HanAll in-license agreement. There were no
acquired in-process research and development expenses for the
fiscal year ended March 31, 2022.
G&A Expenses: General and administrative
expenses were $48.0 million for the fiscal year ended March 31,
2023, compared to $54.2 million for the fiscal year ended March 31,
2022. The decrease was primarily due to lower financial advisory,
legal, and other professional fees, as well as personnel-related
expenses, partially offset by higher market research and
information technology costs.
Net Loss: Net loss was $211.0
million ($1.71 per common share) for the fiscal year
ended March 31, 2023, compared to $156.7
million ($1.43 per common share) for the fiscal year
ended March 31, 2022. Net loss for the fiscal year ended March
31, 2023 and 2022 included $32.3 million and $34.2 million,
respectively, related to non-cash stock-based compensation
expense.
About Immunovant, Inc.Immunovant, Inc. is a
clinical-stage immunology company dedicated to enabling normal
lives for people with autoimmune diseases. As a trailblazer in
anti-FcRn technology, the Company is developing innovative,
targeted therapies to meet the complex and variable needs of people
with autoimmune diseases. For additional information on the
Company, please visit www.immunovant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform
Act of 1995 and other federal securities laws. The use of words
such as "can," “may,” “might,” “will,” “would,” “should,” “expect,”
“believe,” “estimate,” “design,” “plan,” "intend," and other
similar expressions are intended to identify forward-looking
statements. Such forward looking statements include Immunovant’s
expectations regarding the timing, design, and results of clinical
trials of its product candidates; Immunovant's plan to develop
batoclimab and IMVT-1402 across a broad range of autoimmune
indications; Immunovant's beliefs regarding its cash runway; and
the potential benefits of batoclimab’s and IMVT-1402’s unique
product attributes. All forward-looking statements are based on
estimates and assumptions by Immunovant’s management that, although
Immunovant believes to be reasonable, are inherently uncertain. All
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those that
Immunovant expected. Such risks and uncertainties include, among
others: initial results or other preliminary analyses or results of
early clinical trials may not be predictive final trial results or
of the results of later clinical trials; results of animal studies
may not be predictive of results in humans; the timing and
availability of data from clinical trials; the timing of
discussions with regulatory agencies, as well as regulatory
submissions and potential approvals; the continued development of
Immunovant’s product candidates, including the timing of the
commencement of additional clinical trials and resumption of
current trials; Immunovant’s scientific approach, clinical trial
design, indication selection, and general development progress;
future clinical trials may not confirm any safety, potency, or
other product characteristics described or assumed in this press
release; any product candidate that Immunovant develops may not
progress through clinical development or receive required
regulatory approvals within expected timelines or at all;
Immunovant’s product candidates may not be beneficial to patients,
or even if approved by regulatory authorities, successfully
commercialized; the potential impact of global factors, such as the
COVID-19 pandemic, geopolitical tensions, and adverse macroeconomic
conditions on Immunovant’s business operations and supply chain,
including its clinical development plans and timelines;
Immunovant’s business is heavily dependent on the successful
development, regulatory approval and commercialization of
batoclimab and IMVT-1402; Immunovant is at an early stage in
development of for IMVT-1402 and in various stages of clinical
development for batoclimab; and Immunovant will require additional
capital to fund its operations and advance batoclimab and IMVT-1402
through clinical development. These and other risks and
uncertainties are more fully described in Immunovant’s periodic and
other reports filed with the Securities and Exchange Commission
(SEC), including in the section titled “Risk Factors” in
Immunovant’s most recent Annual Report on Form 10-K for the fiscal
year ended March 31, 2023, to be filed with the SEC on May 22,
2023, and Immunovant’s subsequent filings with the SEC. Any
forward-looking statement speaks only as of the date on which it
was made. Immunovant undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
IMMUNOVANT, INC.
Consolidated Statements of
Operations
(In thousands, except share and per share
data)
|
Three Months EndedMarch 31, |
|
Years Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
51,837 |
|
|
$ |
31,986 |
|
|
$ |
160,257 |
|
|
$ |
101,808 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
10,000 |
|
|
|
— |
|
General and administrative |
|
12,422 |
|
|
|
15,241 |
|
|
|
48,019 |
|
|
|
54,225 |
|
Total operating expenses |
|
64,259 |
|
|
|
47,227 |
|
|
|
218,276 |
|
|
|
156,033 |
|
Interest income, net |
|
(3,480 |
) |
|
|
— |
|
|
|
(7,578 |
) |
|
|
— |
|
Other expense (income),
net |
|
(356 |
) |
|
|
(44 |
) |
|
|
253 |
|
|
|
781 |
|
Loss
before provision (benefit) for income taxes |
|
(60,423 |
) |
|
|
(47,183 |
) |
|
|
(210,951 |
) |
|
|
(156,814 |
) |
Provision (benefit) for income taxes |
|
(992 |
) |
|
|
(12 |
) |
|
|
9 |
|
|
|
(84 |
) |
Net loss |
$ |
(59,431 |
) |
|
$ |
(47,171 |
) |
|
$ |
(210,960 |
) |
|
$ |
(156,730 |
) |
Net loss per common share —
basic and diluted |
$ |
(0.46 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.71 |
) |
|
$ |
(1.43 |
) |
Weighted average common shares
outstanding — basic and diluted |
|
129,632,592 |
|
|
|
116,337,733 |
|
|
|
123,075,329 |
|
|
|
109,679,256 |
|
IMMUNOVANT, INC.
Consolidated Balance Sheets
(In thousands, except share and per share
data)
|
March 31, |
|
March 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
|
$ |
376,532 |
|
|
|
$ |
493,817 |
|
|
Accounts receivable |
700 |
|
|
12,229 |
|
|
Prepaid expenses and other current assets |
26,916 |
|
|
6,253 |
|
|
Income tax receivable |
|
|
185 |
|
|
|
|
632 |
|
|
Total current assets |
404,333 |
|
|
512,931 |
|
|
Operating lease right-of-use
assets |
1,172 |
|
|
2,303 |
|
|
Property and equipment,
net |
333 |
|
|
330 |
|
|
Total
assets |
|
$ |
405,838 |
|
|
|
$ |
515,564 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
|
Accounts payable |
|
$ |
1,353 |
|
|
|
$ |
18,629 |
|
|
Accrued expenses |
40,421 |
|
|
24,575 |
|
|
Current portion of operating lease liabilities |
1,173 |
|
|
1,145 |
|
|
Due to Roivant Sciences Ltd. |
350 |
|
|
171 |
|
|
Total current liabilities |
43,297 |
|
|
44,520 |
|
|
Operating lease liabilities, net of current portion |
47 |
|
|
1,219 |
|
|
Total liabilities |
43,344 |
|
|
45,739 |
|
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Series A preferred stock, par value $0.0001 per share, 10,000
shares authorized, issued and outstanding at March 31, 2023
and March 31, 2022 |
— |
|
|
— |
|
|
Preferred stock, par value $0.0001 per share, 10,000,000 shares
authorized, no shares issued and outstanding at March 31, 2023
and March 31, 2022 |
— |
|
|
— |
|
|
Common stock, par value $0.0001 per share, 500,000,000 shares
authorized, 130,329,863 shares issued and outstanding at
March 31, 2023 and 500,000,000 shares authorized, 116,482,899
shares issued and outstanding at March 31, 2022 |
13 |
|
|
12 |
|
|
Additional paid-in capital |
927,976 |
|
|
824,796 |
|
|
Accumulated other comprehensive income |
852 |
|
|
404 |
|
|
Accumulated deficit |
(566,347 |
) |
|
(355,387 |
) |
|
Total stockholders’ equity |
362,494 |
|
|
469,825 |
|
|
Total liabilities and
stockholders’ equity |
|
$ |
405,838 |
|
|
|
$ |
515,564 |
|
|
Contact:Chau Cheng, PhD, MBAVice President,
Investor RelationsImmunovant, Inc.info@immunovant.com
Immunovant (NASDAQ:IMVT)
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